There was a notable uptick in drug approvals by the US Food and Drug Administration (FDA) compared with the same period last year. The agency approved two hepatitis C drugs, Victrelis (boceprevir) and Incivek (telaprevir) as well as a second autologous cell therapy, laViv (azficel-T), for skin wrinkle reduction. The V600E mutation-specific B-RAF inhibitor vemurafenib for melanoma, translation modulator ataluren for cystic fibrosis and monoclonal antibody teplizumab for diabetes showed proof of efficacy in trials.

Notable regulatory approvals (Q2 2011)

Notable regulatory setbacks (Q2 2011)

Notable upcoming regulatory decisions (Q3 2011)

FDA approvals by lead indication area

Notable trial results (Q2 2011)